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Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020

IMPORTANCE: In recent years, drug approvals have been based on fewer, smaller, and less rigorous pivotal trials. Less robust preapproval testing raises questions about the efficacy and clinical value of these drugs. OBJECTIVE: To assess the regulatory context, pivotal design characteristics, and pos...

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Detalles Bibliográficos
Autores principales:	Mitra-Majumdar, Mayookha, Gunter, Simon J., Kesselheim, Aaron S., Brown, Beatrice L., Joyce, Krysten W., Ross, Murray, Pham, Catherine, Avorn, Jerry, Darrow, Jonathan J.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	American Medical Association 2022
Materias:	Original Investigation
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9115615/ https://www.ncbi.nlm.nih.gov/pubmed/35579897 http://dx.doi.org/10.1001/jamanetworkopen.2022.12454

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